Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-95
SponsorUniversity of Minnesota
About this trial
This is a single-arm, two-visit, non-randomized, cross sectional study identified as an intervention due to the use of a single bout of aerobic exercise to assess cerebrovascular function under the NIH rules. This study is not masked and its primary purpose is to develop a basic science understanding of the relationship between cerebrovascular health and balance control with aging. This study will involve 102 individuals classified as younger adults, middle-aged adults, and older adults who are neurotypical and cognitively normal. The primary outcome from a clinical trials perspective will be cerebrovascular response to a bout of aerobic exercise (i.e. change in cerebral blood flow with the performance of aerobic exercise on a recumbent stepper exercise machine). Non-interventional outcomes will be EEG measures of cortical activity and biomechanical kinetic and kinematic data recorded during standing balance reactions, as well as biological blood samples for genomic analysis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age within the following 3 group age ranges, 21-30yo; middle-aged: 40-55yo; older: 65-95yo adults
the absence of major orthopedic disability
cognitively normal (MoCA score ≥ 26/30 in older adult group)
vision that is 20/40 or better with or without corrective lenses, (5) the ability to consent and communicate with researchers
Disqualifiers
insulin-dependent diabetes
peripheral neuropathy
myocardial infarction or symptoms of coronary artery disease within 2 years
congestive heart failure or class IV heart failure
Trial design
Design model
Single group
Treatments tested in this trial
aerobic exercise
Behavioraluse of single bout of aerobic exercise
Treatment groups
102 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
cerebral blood flow velocity assessed using transcranial Doppler ultrasound
Includes recordings from transcranial Doppler ultrasound of cerebral blood flow (CBF) velocity performed at the first session during rest, sit-to-stand, transfer, and single bout of aerobic exercise.
Time frame
1 week2
Kinetic center of pressure rate of rise post-balance perturbation, assessed biomechanically.
Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.
Time frame
1 week3
Prefrontal-M1 coherence an S1-M1 coherence post-balance perturbation, assessed using EEG
Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.
Time frame
1 weekSponsors and contacts
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Source ClinicalTrials.gov